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NCT06628453Recruiting

CGM for Management of Type 2 Diabetes in Pregnancy

Continuous Glucose Monitoring for Management of Type 2 Diabetes in Pregnancy

Source: ClinicalTrials.gov · Last updated 29 Jun 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are: 1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose? 2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose? 3. What other factors increase the risk of maternal and infant complications? Participants will: 1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery 2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis 3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits 4. Have umbilical cord blood collected at delivery for analysis

Status (registry)
Recruiting
Study type
Interventional
Enrollment
564 (estimated)
First submitted
25 Sept 2024
Start date
8 Apr 2025
Primary completion date
Feb 2029
Lead sponsor
University of Alabama at Birmingham
NCT number
NCT06628453

What you commit to

  • Study type: Interventional
  • Planned participants: 564
  • From 8 Apr 2025 to the primary completion date, Feb 2029
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in this trial in a previous pregnancy

Other illness

  • Unable or unwilling to wear CGM due to intolerance to medical-grade adhesives or skin conditions

Other

  • Multiple gestation
  • Major fetal anomaly or two or more minor fetal anomalies
  • Planned delivery outside study consortium
  • Participating in another conflicting interventional study
  • Patient unable to consent
  • Physician refusal for other reasons

Who the study is looking for

  • Type 2 diabetes mellitus treated with daily insulin injections or oral hypoglycemic agents diagnosed before pregnancy or at less than 14 weeks gestation with hemoglobin A1c 6.5% or greater
  • Pregnant with viable fetus at 6 to less than 23 weeks gestation
  • Maternal age 18-50 years old

Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
University of North Carolina, Chapel Hill
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
Prisma Health Greenville Memorial Hospital
Coordinator of this site? Confirm its status
GreenvilleUnited StatesRecruiting
University of Texas Health Science Center at Houston
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Oregon Health and Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
University of California At San Diego
Coordinator of this site? Confirm its status
San DiegoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.